MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RANGER PACLITAXEL-COATED PTA BALLOON CATHETER; DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER

Model Number	1973-03
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Ischemia (1942); Restenosis (4576)
Date of Event	02/21/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that restenosis and ischemia occurred.On (b)(6) 2023, the entire length of the superficial femoral artery to the mid-thigh was treated with a rotablator atherectomy device.This was done without complication.Patient was in a supine position under local anesthesia.A 5.0 x 200mm, 150cm ranger paclitaxel-coated pta balloon catheter was selected and passed to cover the distal right common femoral and the entire affected area of the superficial femoral artery.The balloon was inflated where there was a very significant waist in the more distal stenosis requiring increased pressure up to 12 atmospheres, but ultimately complete expansion was obtained.Inflation was held for 3 minutes, deflated and then removed.Repeat angiogram showed wide patency to the superficial femoral artery end through the previously placed stent with no evidence of a dissection.Runoff films showed no evidence of any distal embolization.Due to the significant scarring and obstructed disease in the left groin a closures device was not used.The patient was taken to recovery area in stable condition.On (b)(6) 2024, right common femoral and profunda femoral arteries had patency.Right superficial femoral artery patent proximally including superficial femoral artery stent located just past its origin though there is in-stent restenosis noted.Severe scattered disease throughout the superficial femoral and popliteal arteries with many areas of severe stenosis and complete occlusion just past hunters canal with reconstitution of the popliteal above the knee.Right superficial femoral and popliteal arteries were treated by atherectomy with balloon angioplasty, and additional selective catheter placement was done with elective angiography.The common femoral artery end popliteal was treated by atherectomy before angioplasty to provide plaque modification and minimize risk of dissection end therefore need for further peripheral stenting.The superficial femoral and popliteal arteries were treated with a rotablator without complications.A 5 x 3mm drug-coated balloon was advanced for balloon angioplasty.Wire and catheter taken up into the abdominal aorta end aortogram performed.Wire and catheter taken over the aortic bifurcation and down into the right common femoral artery and right leg angiogram performed.Heparin bolus administered; sheath exchanged for a 6 french by 45 synovator long sheath.Wire and catheter taken down the superficial femoral and popliteal arteries with selective angiography performed at each level.Superficial femoral/popliteal occlusions grossed and catheter taken down to the below-knee popliteal artery, angiogram performed confirming that we were in fact in the popliteal flow lumen.Completion angiogram performed.Groin soft and hemostatic at completion.

• Brand Name: RANGER PACLITAXEL-COATED PTA BALLOON CATHETER
• Common Device Name: DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): HEMOTEQ AG; adenauerstrasse 15; wuerselen 52146 ; GM 52146
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18916333
• Report Number: 2124215-2024-15734
• Device Sequence Number: 17903007
• Product Code: ONU
• UDI-Device Identifier: 08714729976042
• UDI-Public: 08714729976042
• Combination Product (Y/N): Y
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P190019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/10/2024
• Device Model Number: 1973-03
• Device Catalogue Number: 1973-03
• Device Lot Number: 09403H22
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/23/2024
• Initial Report FDA Received Date: 03/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/11/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 50 YR
• Patient Sex: Female
• Patient Race: White